ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)— 510(k) K952096

Name: FDA 510(k) clearance K952096
Creator: U.S. Food and Drug Administration
Published: 1995-08-17

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K952096 for ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE), Substantially Equivalent on 1995-08-17. Applicant: Tcpi, Inc.. Device class: 2.

Clearance details

Applicant: Tcpi, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1995-05-04
Decision date: 1995-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

Download summary PDF View on FDA.gov ↗

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